1. Field of the Invention
The present invention relates to a process and a method for producing osteoinductive particulate bone compositions or preparations, where the bone particles have improved osteoinduction activity and to methods for making and using same.
More particularly, the present invention relates to a process and a method for producing osteoinductive particulate bone compositions or preparations including a distribution of bone particles sizes, where the particles sizes are less that 355 μm or simply 355μ and where the bone particles have improved osteoinductive activity.
2. Description of the Related Art
It is well known that implantation of bone decalcified with hydrochloric acid or of demineralized bone matrix into musculature of rodents leads to heterotopic bone formation (Urist, et al. 1983 and others). In fact, this is a standard laboratory test devised by Urist for the detection of bone morphogenetic protein (BMP) activity in various bone preparations. However, rodent animal models have a limitation, as these animals are peculiar in their ability to produce heterotopic cancellous bone in response to implantation of several tissues including bone and various bone preparations. Whether this parallels response in higher animals or in humans is unknown. However, the rodent animal model is a convenient one and it is easy to use.
It has been shown as early as the 1950's (LaCroix) that exposure of bone (autologous or allogeneic) to alcohol or to heat markedly diminishes its osteoinductive capacity. It has been also established, but is not necessarily acknowledged that intraosseous lipids serve as vehicle for BMP. Extraction of the same from bone allografts would likely interfere with the delivery of BMP or other growth factors at the site of osteoinductivity.
Thus, there is a need in the art for a particulate bone preparation that has superior initial osteoinductive capacity than traditional demineralized or chemically extracted bone.